NUsurface Implant Registry (NIR)

A Long-term Non-interventional Registry Study to Assess the Effectiveness and Safety of the NUsurface® Meniscus Implant

The purpose of this active post-market surveillance clinical registry study is to further characterize the therapeutic effect, the long-term safety and effectiveness of the NUsurface® meniscus implant in the real-world post-marketing setting

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Meniscus; Degeneration; Knee Pain Chronic

Detailed Description

Patients eligible for the Registry includes any patient who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria (Evidence of a personally signed and dated informed consent document). The NUsurface Implant Regitstry is about data collection only and under routine standard of care by treating physician. Data collection points are pre-op (i.e. baseline), surgery and multiple times after surgery during the first 6 months to correspond to clinic standard of care schedules, 6 months, 1 year post-operatively and then yearly thereafter out to 10 years.Surveys used are KOOS; Knee injury and Osteoarthritis Outcome Score & WOMET; Western Ontario Meniscal Evaluation Tool.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Rita Molenaar; Phone Number: +31.343.200.140; Email: r.molenaar@activeimplants.com
• Study Contact Backup: Name: Ryan Belaney, MSBME; Phone Number: 901 762 0352; Email: ryan.belaney@activeimplants.com

Study Locations

• Belgium
  • Deurne, Belgium, BE-2100
    • Recruiting
    • AZ Monica vzw
    • Contact: Kristien Vuylsteke; Phone Number: +32 (0)3 320 58 42; Email: morefoundation@azmonica.be
    • Principal Investigator: Peter Verdonk, MD PhD
• Germany
  • Berlin, Germany, 10627
    • Recruiting
    • Sporthopaedicum
    • Contact: Nina Bauer; Phone Number: +49 (0)30 92105993; Email: bauer@arthroskopie.de
    • Principal Investigator: Sven Scheffler, MD PhD
  • Brandenburg an der Havel, Germany, 14770
    • Recruiting
    • University of Brandenburg
    • Contact: Mrs Lehman; Phone Number: +49 3381-41-1900; Email: orthopaedie@klinikum-brandenburg.de
    • Principal Investigator: Roland Becker, MD PhD
    • Sub-Investigator: Sebastian Kopf, MD PhD
  • Damme, Germany, 49401
    • Recruiting
    • St. Elisabeth Krankenhaus
    • Contact: Rianne Berg; Phone Number: +49 05491 955232; Email: rianne.berg@orthop-damme.de
    • Principal Investigator: Berg Tom, MD
  • München, Germany, 81377
    • Recruiting
    • Klinikum der Universität München
    • Contact: Monika Baylacher; Phone Number: 0049-(0)89-4400-57670; Email: monika.baylacher@med.uni-muenchen.de
    • Principal Investigator: Peter Müller, MD PhD
    • Sub-Investigator: Thomas Niethammer, MD
• Israel
  • Tel Aviv, Israel, 6971028
    • Withdrawn
    • Assuta Medical Center
  • Zerifin, Israel, 70300
    • Terminated
    • Shamir Medical Center
• Netherlands
  • Maastricht, Netherlands, 6229HX
    • Recruiting
    • Maastricht UMC
    • Contact: Liesbeth Jutten-Brouwer, MSc; Phone Number: +31 43 387 7144; Email: trialbureau.orthopedie@mumc.nl
    • Principal Investigator: Pieter Emans, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population eligible for this protocol includes any subject who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria

Description

Inclusion Criteria:

• New or current treatment with the NUsurface® meniscus implant
• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the Registry.

Exclusion Criteria:

• There are no protocol exclusion criteria; all subjects who meet the inclusion criteria are eligible for enrollment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS (Knee Osteoarthritis Outcome Score) Pain improvement	a responder is defined as a patient with an increase of at least 20 points on the KOOS pain assessment	24 months
WOMET (Western Ontario Meniscus Evaluation Tool) score improvement	a responder is defined as a patient with an increase of at least 12 points on the WOMET assessment	24 months

Collaborators and Investigators

• Sponsor: Active Implants
• Investigators: Study Director: Richard W Threharne, PhD, Active Implants LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2033

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 01003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No